Theraclion (EPA:ALTHE) said today that the 1st patients were treated in the U.S. pivotal clinical trial evaluating the safety and efficacy of the company’s Echopulse echotherapy device as a non-invasive treatment for breast fibroadenomas.
The clinical trial is slated to enroll 100 patients, the France-based company said, at 4 sites across the U.S. and 1 site in Germany.
Patients will receive a single high-intensity treatment with Echopulse. The study’s primary endpoint is a reduction of fibroadenoma volume, pain and anxiety.
“High intensity focused ultrasound (HIFU) technology is exciting because it has the potential to provide patients with an alternative to surgery, avoiding a scar, with minimal interruption in their normal daily activity,” principal investigator Dr. David Brenin said in prepared remarks.
Echopulse, a non-invasive tumor therapy using ultrasound-guided high-intensity focused ultrasound, won the CE Mark for regulatory approval in the European Union for non-invasive ablation of breast fibroadenomas and thyroid nodules.
“The U.S. market for non-invasive treatment alternatives for BFA is significant. There are approximately 400 thousand surgeries to remove BFAs in the U.S. each year,” Theraclion CEO David Caumartin added. “We believe that patients are searching for alternatives to invasive surgery that are outpatient, of short duration, generate minimal or no post-treatment pain and no scarring. This clinical trial is a significant step toward bringing our Echopulse echotherapy to U.S. patients.”